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Type 1 DiabetesNCT06331429

Emoticare: Serious Game for the Adaptation to the Disease of Adolescents With Type 1 Diabetes Mellitus.

A study testing EmoTiCare in people with Type 1 Diabetes and Adolescent Development, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. Read more about this study

Who is it for?
Ages 12 to 16 years
Conditions the study is for
Type 1 Diabetes, Adolescent Development
What is being tested?
EmoTiCare
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSpain
Study dates
22 Jul 2024to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosis of Diabetes mellitus type 1 (6 months from diagnosis)
  • Informed consent by parents/guardians and participants

Who cannot join

  • Diagnosis other than type 1 diabetes mellitus
  • No access to internet or new technologies
  • Not speaking Spanish

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universitat de València

    Valencia

Other trials in Spain

About this study

Official title: Smart Technology Platform for Socio-emotional Development and Health Promotion: Implementation and Validation of a Serious Game in Adolescentes With DM1

The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. To foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. Such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. Presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges.

The platform integrates new technologies for assessment and intervention. Ecological Momentary Assessment enables real-time evaluation, with data transferred to the technological platform. Artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. Ecological Momentary Intervention is employed for in-context treatments in participants' daily lives and natural environments. A serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. The game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. It addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness.

Being tested
EmoTiCare
Keywords
Type 1 Diabetes, Serious Game, Technology platform, Psychological intervention, Adolescence, Quality of life
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmoTiCareBehavioural

    The EMOTICARE technological platform intervenes in users through a serious game, i.e. a video game whose main purpose is to teach or provide the player with certain skills that serve to achieve a higher purpose than the game itself.

    The game works in 6 areas, each of which refers to one of the variables that are analysed or considered important in the adaptation to the disease: Area 1. Psychoeducation of DM1; 2. Emotional awareness and expression; 3. Emotional regulation; 4. Problem solving; 5. Self-esteem and identity;6. Social skills and communication

Study groups in NCT06331429
Study groupRoleWhat they receive
Control GroupNo interventionPatients who receive the treatment program, will previously constitute their own control group (waiting list control group).
Experimental groupExperimentalAdolescents who receive the treatment program, will previously constitute their own control group (waiting list control group). Thus, diagnostic measures will be obtained in all of them in an initial evaluation (T1), and after 6 weeks of this assessment the treatment program will be started. In the first contact session at 6 weeks after T1 all adolescents will be re-assessed (T2) and after this the treatment program will be started (within an estimated time of 15 days maximum from this second pre-treatment evaluation, the estimated duration of treatment being 6 weeks). After the completion of the serious game, a new asssesment pass will be performed (T3) in order to assess the post-treatment change. Thus, the estimated time between T2 and T3 will be equivalent to that between T1 and T2, being 6 weeks.
Receives: Behavioral: EmoTiCare

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change Quality of Life (Baseline-Pre-Post)

    KIDSCREEN-27. This scale consists of 27 items in 5 subscales. Physical well-being, mood, family life, school life, peer relations. Scores range from 27 to 135. Higher scores indicate a higher quality of life in general and in each of the subscales.

    First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: PRE- Up to 6 weeks after the first measurement, the second measurement of the same variable was carried out.

    Third measurement: POST Up to 6 weeks after the second measurement, the third measurement of the same variable was carried out.

    Measured: Baseline up to 12 weeks

  2. Change Emotional and Behavioral Problems (Baseline-Pre-Post)

    SDQ: This questionnaire is used to assess the possible presence of psychopathology and the emotional and behavioural adjustment of adolescents. It is a 25-item Likert-type (1-3) questionnaire. The items of this questionnaire are divided into 5 subscales: emotional symptomatology, conduct problems, hyperactivity, peer problems and prosocial behaviour. Higher scores on each scale indicate greater difficulties. First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: PRE- Up to 6 weeks after the first measurement, the second measurement of the same variable was carried out.

    Third measurement: POST Up to 6 weeks after the second measurement, the third measurement of the same variable was carried out.

    Measured: Baseline up to 12 weeks

  3. Change Emotional Competences (Baseline-Pre-Post)

    EAQ-30: This questionnaire consists of 30 Likert-style items (1-False to 3-True), and aims to identify how adolescents think about their feelings, as well as the degree to which they feel them and the ability to express them. In addition to an overall score, this tool is composed of 6 subscales that attempt to describe different aspects of emotional functioning. Higher scores indicate greater use of emotional awareness and regulation strategies.

    First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: PRE- Up to 6 weeks after the first measurement, the second measurement of the same variable was carried out.

    Third measurement: POST Up to 6 weeks after the second measurement, the third measurement of the same variable was carried out.

    Measured: Baseline up to 12 weeks

  4. Change Self-concept (Baseline-Pre-Post)

    CAG: This questionnaire aims to measure self-concept in adolescents from a multidimensional perspective. It consists of 48 Likert-type response items ranging from 1 to 5, providing a score range of 48 to 240. Physical Self-Concept, Social Acceptance, Family Self-Concept, Intellectual Self-Concept, Personal Self-Assessment, and Sense of Control. The questionnaire provides an overall self-concept score, as well as scores for 6 subdimensions: Higher scores indicate higher self-concept.

    This is the first measurement. After obtaining the participant's informed consent, we assessed the initial score for this outcome.

    The second measurement, labeled PRE, was conducted up to 6 weeks after the first measurement of the same variable.

    The third measurement, labeled POST, was carried out up to 6 weeks after the second measurement.

    Measured: Baseline up to 12 weeks

  5. Change Coping (Baseline-Pre-Post)

    Social Problem Solving Inventory- Revised (SPSI-R). This questionnaire attempts to reflect the cognitive, affective and behavioural responses to the problems of daily life or the different difficulties we try to solve. This reduced version consists of 25 Likert-type items, grouped into the following 5 dimensions: Rational problem solving, Avoidant style, Impulsive style, Positive problem orientation and Negative problem orientation. Higher scores on each dimension signify the coping style used by the adolescent.

    First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: PRE- Up to 6 weeks after the first measurement, the second measurement of the same variable was carried out.

    Third measurement: POST Up to 6 weeks after the second measurement, the third measurement of the same variable was carried out.

    Measured: Baseline up to 12 weeks

  6. Change Social Skills (Baseline-Pre-Post)

    CHASO: It consists of 40 Likert-type response items ranging from 1 to 5 (1 - Very uncharacteristic of me; 5 - Very characteristic of me) and assesses a total of 10 skills: 1. Interacting with strangers; 2. Dealing with criticism; 4. Interacting with people I am attracted to; 5. Staying calm in the face of criticism; 6. Public speaking/interacting with superiors; 7. The scores for each of these skills are calculated from the sum of the items that make them up. Higher scores indicate higher social skills.

    First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: PRE- Up to 6 weeks after the first measurement, the second measurement of the same variable was carried out.

    Third measurement: POST Up to 6 weeks after the second measurement, the third measurement of the same variable was carried out.

    Measured: Baseline up to 12 weeks

Secondary outcomes (3)

  1. Change Threat of disease(Baseline-Pre-Post)

    The Brief Illness Threat Questionnaire (BIP-Q) is used, which consists of 5 items with a Likert scale from 0 to 10. This questionnaire mainly assesses consequences of the illness, duration of the illness, identity, worry about the illness and emotional impact of the illness. The scale is interpreted so that the higher the score, the greater the sense of perceived threat.

    First measurement: After the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: PRE- Up to 6 weeks after the first measurement, the second measurement of the same variable was carried out.

    Third measurement: POST Up to 6 weeks after the second measurement, the third measurement of the same variable was carried out.

    Measured: Baseline up to 12 weeks

  2. Change Psychoeducation Diabetes

    Psychoeducation of the disease: the ECODI Diabetes knowledge scale will be used to assess this variable. This scale consists of 25 items and four dimensions: basic knowledge and self-care, laboratory values, diet and physical exercise. It is a scale that is corrected by the number of hits and misses.

    Psychoeducation about the disease: The ECODI diabetes knowledge scale is used to assess this variable. This scale consists of 25 items and four dimensions: basic knowledge and self-care, laboratory values, diet and exercise. It is a scale that is corrected by the number of hits and misses.

    Measured: Start of the game and during the game

  3. Change Resilience (Baseline-Pre-Post)

    Connor-Davidson Resilience Scale to assess the ability to cope with stress and adversity. The resilience scale is made up of 10 items, with a range of scores from 0 to 40, with higher scores indicating greater resilience.

    First measurement: Once the participant had signed the informed consent, the initial score for this outcome was assessed.

    Second measurement: PRE- Up to 6 weeks after the first measurement the second measurement of the same variable was carried out.

    Third measurement: POST Up to 6 weeks after the second measurement the third measurement of the same variable was carried out.

    Measured: Baseline up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start22 Jul 2024
  3. Primary completion1 Sep 2024
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06331429
Sponsor's protocol ID
EmoTiCare
Status last verified
May 2026
First submitted
19 Mar 2024
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Martin-Avila J, Rodriguez-Jimenez E, Valero-Moreno S, Gil-Gomez JA, Montoya-Castilla I, Perez-Marin M. The impact of the emoTICare program on socioemotional adjustment and psychological well-being in adolescents with type 1 diabetes mellitus. Front Endocrinol (Lausanne). 2025 Oct 3;16:1668398. doi: 10.3389/fendo.2025.1668398. eCollection 2025.

    PubMed 41113700

Questions about this trial

What is this clinical trial studying?

A study testing EmoTiCare in people with Type 1 Diabetes and Adolescent Development, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change Quality of Life (Baseline-Pre-Post) (time frame: Baseline up to 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06331429, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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